Language Development in Preterm Children

Overview

This trial is active, not recruiting.

Condition

language development

Sponsor

Stanford University

Start date

January 2010

End date

February 2018

Trial size

100 participants

Trial identifier

NCT01599780, 18354

Summary

This research investigates the ways in which preterm birth affects how very young children
learn to speak and understand language, and how older children gain efficiency in language
processing. The investigators observe how children at different ages learn new words and
comprehend familiar words, how they communicate effectively with others, and how they use
both linguistic and non-linguistic skills in problem-solving. All of the activities in the
investigators' studies are designed to be age-appropriate and fun for children.

Additional Information

Official title

On- and Off-line Measures of Language Development in Preterm Children

Principal investigator

Heidi M Feldman, MD/PhD

Description

In a typical session, the investigators video-record your child participating in one or more
engaging activities with you and/or a member of the staff.
- In one type of task, your child looks at colorful pictures on a video screen while
listening to recorded speech referring to the pictures. The investigators may vary
factors in the speech stimuli such as word familiarity or sentence structure to learn
more about the development of language understanding. Your child is seated on your lap
throughout the session. From the video record, the investigators can later look at your
child's gaze patterns in response to speech.
- In another type of task, the investigators observe children interacting with a staff
member in the playroom. In these game-like activities, your child may be asked to play
with toys, name or point to pictures, repeat sequences of words or sentences, tell
stories, imitate hand movements, or solve puzzles. These observations help the
investigators understand how language development relates to other types of cognitive
activities in children at different ages.
- In a third type of task, the investigators observe how children interact spontaneously
in a less structured situation. In some cases, the investigators observe you as you
play with your child in a playroom. The investigators will provide you with a selection
of toys appropriate to your child's age, and ask you to engage with your child as you
would at home. From these observations, the investigators learn how children at
different ages respond to language in the context of social interaction.
The investigators may also collect a language questionnaire and similar forms containing
basic information about your child's development. Additionally, the investigators may
review your child's medical records, including ultrasounds and MRI scans, to gain a better
understanding of your child's medical history. All information is used for purposes of
basic research on language learning only, and will not constitute a clinical assessment or
evaluation.
TIME INVOLVEMENT
In this longitudinal study, each child is expected to come for a total of 12-14 sessions of
behavioral testing, spread out over 2.5 years. Children are tested in 2 sessions (sessions
occur approximately one week apart) at ages 18 (chronological), 18 (adjusted; applicable to
pre-terms), 24, 30, 36, 42, and 48 months. Each session typically lasts from 30 to 60
minutes, depending on the age of the child and number of breaks taken.
RISKS AND BENEFITS
There are no foreseeable risks or discomforts to you or your child in participating in this
research. All the procedures are observational and non-intrusive. The investigators pace
each session appropriately and give breaks as needed to enable your child to enjoy and
complete the session. Your child will not be pressured to continue in the event that he or
she becomes upset, tired, or resistant at any point during the session. If for any reason
you or your child does not want to continue, the session will be ended immediately with no
penalty.
The investigators cannot and do not guarantee or promise that you will receive any benefits
from this study, apart from the payment and the satisfaction of participating in
developmental research. If appropriate, the investigators provide information regarding
resources that may be helpful in addressing any concerns regarding your child's development.
There are no direct costs to you for participating in this study. Neither you, nor your
insurance provider, will be charged for the costs of any of the procedures performed for the
purpose of this research study. The National Institute of Health is providing financial
support for this study.
PARTICIPANT'S RIGHTS
If you have read this form and have decided to allow your child to participate in this
project, please understand your child's participation is voluntary and your child has the
right to withdraw his/her consent or discontinue participation at any time without penalty
or loss of benefits to which he/she is otherwise entitled. Your child has the right to
refuse to answer particular questions. The video record of the session will be identified by
a code number, not by name. This record will be accessible only to the project directors and
members of the project staff, unless you give your explicit permission for others to view it
for scientific or educational purposes. All records will be stored securely so that your
child's individual privacy will be maintained. In addition, your child's identity will
remain private in all publications resulting from the study. Five years following the
completion of your child's participation in this study, the investigators will destroy all
raw videotapes.

Trial information was received from ClinicalTrials.gov and was last updated in December 2014.